EP3766446B1 - Einrichtung zur durchführung eines elektrochirurgischen eingriffs an einem patienten - Google Patents

Einrichtung zur durchführung eines elektrochirurgischen eingriffs an einem patienten Download PDF

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Publication number
EP3766446B1
EP3766446B1 EP19187086.4A EP19187086A EP3766446B1 EP 3766446 B1 EP3766446 B1 EP 3766446B1 EP 19187086 A EP19187086 A EP 19187086A EP 3766446 B1 EP3766446 B1 EP 3766446B1
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EP
European Patent Office
Prior art keywords
sensor
patient
signal
generator
switch
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP19187086.4A
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German (de)
English (en)
French (fr)
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EP3766446C0 (de
EP3766446A1 (de
Inventor
Ulrich Biber
Ovidiu Jurjut
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Erbe Elecktromedizin GmbH
Original Assignee
Erbe Elecktromedizin GmbH
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Publication date
Application filed by Erbe Elecktromedizin GmbH filed Critical Erbe Elecktromedizin GmbH
Priority to EP19187086.4A priority Critical patent/EP3766446B1/de
Priority to PL19187086.4T priority patent/PL3766446T3/pl
Priority to US16/923,791 priority patent/US12042213B2/en
Priority to RU2020122551A priority patent/RU2822634C2/ru
Priority to JP2020118393A priority patent/JP7522597B2/ja
Priority to KR1020200086131A priority patent/KR20210010824A/ko
Priority to BR102020014310-7A priority patent/BR102020014310A2/pt
Priority to CN202010691878.XA priority patent/CN112315575A/zh
Publication of EP3766446A1 publication Critical patent/EP3766446A1/de
Application granted granted Critical
Publication of EP3766446C0 publication Critical patent/EP3766446C0/de
Publication of EP3766446B1 publication Critical patent/EP3766446B1/de
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    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/1206—Generators therefor
    • A61B18/1233—Generators therefor with circuits for assuring patient safety
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Definitions

  • the invention relates to a device for carrying out an electrosurgical procedure on a patient, particularly in urology.
  • the DE 32 38 123 A1 Before placing an air cushion under the buttocks or under the two lower legs of a patient during an operation on the urinary bladder.
  • the air cushion is filled with air to such an extent that the patient's buttocks or both lower legs float on a cushion of air.
  • This air cushion is connected with a hose to an airtight container which has approximately the same volume as the air cushion. If the patient lies calmly on the air cushion, it is Air pressure in the air cushion and in the vessel is the same. When the patient moves, the air pressure within the air cushion changes. Such pressure changes are detected using a pressure-dependent switch.
  • a throttle valve is arranged in the hose and is set so that only rapid pressure changes resulting from rapid twitching of the patient generate a sufficiently high pressure difference to allow the pressure-dependent switch to respond.
  • a system in which an acceleration sensor or a gyroscope is attached to the patient in order to detect a movement of the patient and, if necessary, to switch off a generator with which an electrosurgical instrument is fed.
  • the acceleration sensor can be used to detect a patient's twitching before the corresponding limb has traveled a significant distance. Therefore, a shutdown can occur when a movement actually occurs or a movement is just beginning.
  • the surgical device is particularly suitable for carrying out an electrosurgical procedure on a patient, for example for carrying out a transurethral electroresection of the urinary bladder, a transurethral electroresection of the prostate or a transcervical resection (TURB, TURP, TCR).
  • the facility includes a device with a generator Generation of a treatment voltage with which the instrument is to be supplied.
  • the device also includes a control device for controlling the generator. Controlling the generator includes at least switching it on and off.
  • the control of the generator can also include the definition of an operation mode, such as cutting, ablation, coagulation, etc. Different operation modes are achieved by setting different generator voltages and/or different voltage modulations on the generator.
  • the voltage modulation can be, for example, pulse width modulation, frequency modulation or the like.
  • the device also includes a sensor that is designed to be attached to the patient and to detect movement of the patient.
  • the sensor is connected to the control device. This means that muscle contractions caused by neuromuscular stimulation can be quickly recognized and used to implement a control signal. For example, if an undesirable movement by the patient is detected, the generator can be switched off or its operation can be influenced in some other way.
  • the control device can be set up to reduce the power of the generator and/or vary the modulation of the HF voltage and/or switch off the generator temporarily or permanently when an undesirable movement of the patient is detected.
  • the neuromuscular stimulation can be quickly eliminated and the muscle contractions can therefore be limited to a level that is not disruptive, in particular not dangerous. This avoids bladder wall perforations due to muscle contractions or other surgical complications.
  • the senor is a position sensor, a motion sensor or an acceleration sensor.
  • the signal emitted by the sensor designed as a position sensor can be differentiated in time (derived based on time) one or more times in order to generate a signal that indicates sudden movements. This prevents unwanted shutdowns due to slow or small movements of the patient, which are harmless to the result of the operation. However, sudden twitches or violent movements are detected right from the start.
  • the sensor generates corresponding signals that are evaluated by the signal evaluation circuit and used to switch off the generator.
  • the sensor advantageously has a fastening device by means of which it can be fastened to an extremity, in particular a foot or a leg of the patient, for example to his calf.
  • a suitable fastening device is a band that wraps around the patient's extremity at a suitable point or an adhesive surface provided on the sensor, with which the sensor is attached to the patient's skin in an adherent manner.
  • the control device advantageously has a signal evaluation device which is set up to compare the signal supplied by the sensor or a signal derived from it by means of a signal processing device with a threshold value and to generate a switch-off signal if the threshold value is exceeded.
  • the signal processing device can contain one or more filters (high pass, low pass, band pass), linear or non-linear amplifiers and the like.
  • a first threshold value can be set at an acceleration of approximately 3 m/s 2
  • the second threshold value which is intended to lead to a shutdown, ie a safety shutdown, is at an acceleration of, for example, 11 m/s 2 .
  • the control device can be set up to block the generator after a switch-off signal has been generated and to request a manual release. Alternatively, it can be set up to generate the switch-off signal for a defined period of time, for example 3s. Within this period of time, the surgeon can decide how he would like to proceed.
  • control device with an adjustment device with which the time period for the shutdown can be adjusted. It is also possible to provide the control device with input elements for setting the first and/or second threshold value. Furthermore, the control device can have a control element for deactivating that part of the control device that monitors the signal coming from the sensor.
  • the output of a switch-off signal occurs without delay and therefore preferably within less than 30 ms, preferably less than 20 ms after the start of noticeable motor activity of the extremity provided with the sensor.
  • the output of a switch-off signal occurs without delay and therefore preferably within less than 30 ms, preferably less than 20 ms after the start of noticeable motor activity of the extremity provided with the sensor.
  • the movement paths of the extremities caused by the muscle contraction are still very small, so that the manual activity of the surgeon is not significantly disturbed, even during difficult operations.
  • the device according to the invention can be used both for bipolar instruments that have two electrodes and for monopolar instruments that do not have their own counter or neutral electrode and for which a neutral electrode has to be attached to the patient.
  • the sensor for detecting a movement in particular an acceleration of an extremity of the patient, to or in the neutral electrode, which is then to be arranged, for example, on the patient's calf.
  • the invention can also be implemented on devices whose device's own control device is not set up to evaluate sensor signals.
  • a section that is then assigned to the control device can be arranged outside the device.
  • Such a section connected to the sensor can, for example, be mounted in an activation switch, for example a foot switch or a separate housing, which is connected between the activation line coming from the instrument or a foot switch and the activation input of the device.
  • FIG. 1 An operating situation is illustrated in which a patient 11 is positioned on a table 12 for carrying out a surgical procedure, which is to be carried out, for example, in a body cavity 13 of the patient, for example in the urogenital tract.
  • an instrument 14 is inserted into the patient 11 and is connected to a feeding device 15.
  • the instrument 14 is, for example, a probe 16 which has a rigid or flexible shaft 17 and an electrode 18 at the end. As shown, this can be a monopolar instrument.
  • a neutral electrode 19 is attached to the patient 11, which is formed, for example, by a current-distributing, electrically conductive adhesive plaster.
  • the device 15 contains a generator 20 which is suitable for emitting an HF voltage suitable for carrying out a surgical procedure. This is typically in the range of over 100 V, preferably over 200 V, with a frequency of over, preferably well over 100 kHz.
  • the HF voltage can be unmodulated or modulated, for example pulse width modulated.
  • the electrode 18 of the instrument 14 is, as in Figure 1 shown, connected via an electrical line L to an output of the generator 20.
  • the neutral electrode 19 is connected to the other output of the generator 15 via a line M.
  • the generator 20 can, like it Figure 3 illustrated, consist of a high-frequency power oscillator, the switching element 21 of which excites a resonant circuit 22, from which the supply voltage for the instrument 14 is coupled out in a transformer or other way.
  • a control device 23 is used to control the generator 20, which acts, for example, on the switching element 21 in order to control the resonant circuit 22 to excite continuously or in pulses.
  • the device 15 includes a power supply or another power source P for supplying the control device 23 and the generator 20.
  • the control device 23 is at least set up to activate and deactivate the generator 20.
  • the switching element 21 is continually opened and closed, while in the deactivated phase it remains open (non-conductive).
  • the control device 23 contains an activation block 24, with an activation input I, which is connected to an activation switch 25. This can preferably be operated manually and is designed, for example, as a foot switch or as a switch on the instrument 14.
  • the activation block 24 also has a blocking input 0, which is connected to a switch-off block 26.
  • the switch-off block has an input E to which a sensor 27 is connected.
  • the sensor 27 can be designed as a position sensor or, as is preferred, in particular as an acceleration sensor.
  • the sensor 27 is suitable for converting its movement into an electrical signal.
  • the sensor 27 is suitable for emitting a signal corresponding to the speed of movement or the acceleration.
  • the shutdown block 26 is in Figure 4 illustrated separately. It can, for example, have a comparator 28, which compares the signal coming from the sensor 27 with a threshold value sa, which is provided, for example, by a threshold value transmitter 29.
  • the signal present at the output of the comparator 28 indicates cases in which the signal emitted by the sensor 27 is larger is than the threshold sa.
  • the output signal of the comparator 28 can be fed to further processing, for example in a block 30.
  • This can fulfill additional functions as desired. Such functions can be: generating a locking signal for a predetermined or adjustable period of time, permanently generating a switch-off signal until a reset or similar.
  • a reset signal can be given, for example, by the activation switch 25 or a separate reset switch.
  • a signal processing device for example in the form of a digital signal processor DSP, can be arranged between the sensor 27 and the input E of the switch-off block. This can be programmed to filter or otherwise process the signal emitted by the sensor 27.
  • Such signal processing may include filter blocks, amplifier blocks, pattern recognition blocks or the like. Filter blocks can be low pass, high pass, band pass. Amplifier blocks can be linear or non-linear amplifier blocks.
  • the sensor 27 detects the movement, in particular the speed or acceleration of the movement. If the signal emitted by the sensor 27 exceeds the threshold value sa set by the threshold value transmitter 29, a switch-off signal is generated.
  • the processing block 30, if it is designed, for example, as a mono-flop, can then generate a switch-off signal for a fixed or predetermined period of time, for example for 3 s, which is given to input 0 of the activation block 24. This thus switches off the activation of the generator 20.
  • the generator 20 is switched off and it no longer emits any voltage, at least for the blocking time specified by the processing block 30. This effectively prevents further irritation of the nerve and thus greater leg movement.
  • the treatment process is at least briefly interrupted at this point, significant risks of injury caused by sudden leg movements of the patient 11 are avoided. This also effectively avoids surgical complications that could otherwise occur.
  • a first addition which is possible in all of the embodiments described above and below, is the use of several sensors 27, which can be attached to different locations on an extremity or to different extremities, in particular on both legs of the patient 11.
  • the signals of both or several sensors are summed and fed to the input E of the comparator 28.
  • a separate comparator with its own input can also be provided for each sensor, whereby the output signals of these compaparators can be logically linked so that a switch-off occurs when at least one of the comparators delivers a switch-off signal (OR operation).
  • the switch-off block 26 can be designed according to any of the previously described embodiments and can be set up to monitor one or more sensors. In the event of a shutdown, it can, for example, interrupt or short-circuit the signal to be given by the activation switch 24 to the input I of the control device 23.
  • the shutdown block can also be arranged in the instrument 14, particularly if the activation switch 25 is attached to the instrument. It is advantageous if the sensor 27 is connected to the switch-off block via a wireless connection.
  • the shutdown block can be connected to the generator output of the generator 20, for example in order to short-circuit the voltage present there during a shutdown event.
  • the switch-off block 26 can alternatively be integrated into the instrument 14.
  • the sensor 27 is in Figure 7 schematically illustrated separately. It can be designed as a wireless sensor and wirelessly transmit the signal generated by it, for example characterizing the speed of movement or the acceleration, to the switch-off block 26. Alternatively, the sensor 27 can be provided with a cable 31 which is to be connected to the connection E of the switch-off block 26.
  • the sensor 27 may be provided with an adhesive surface 32 for attachment to the patient, which is coated with adhesive or glue to enable attachment to the patient's skin.
  • a fastening strap can be attached to the sensor 27, with which the sensor can be strapped to the patient.
  • each of the described embodiments can be supplemented by a monitoring block that is connected to the signal emitted by the sensor.
  • the monitoring block can be set up to classify the signal emitted by the sensor 27 as a valid signal only if it goes beyond the background noise emanating from the sensor 27 and thus indicates omnipresent micromovements of the patient 11. If such signals are no longer received, the switch-off block 26 can signal that the sensor signal is invalid. It can be provided that the monitoring block shuts down (blocks) the generator 20 in such a case.
  • bipolar instruments 14' such as one in Figure 6 is illustrated schematically.
  • the electrode 18 and an additional neutral electrode 19' are attached to this instrument 14 '.
  • both lines L and N lead from the instrument 14 to the generator 20.
  • the above description applies to all versions that do not specifically include the neutral electrode 19 Figure 8 concern, accordingly.
  • the invention consists in the refined monitoring of the sensor signal by comparing it not only with the threshold value for switching off sa, but also with a lower threshold value sw in order to be able to warn the surgeon about the presence of neuromuscular reactions.
  • Figure 9 illustrates the function of a corresponding switch-off block. This is set up to first compare the signal S with the threshold value sa for switching off and, when this is reached, to emit a switch-off signal. However, if the threshold value sa is not reached, the signal S is compared with a lower threshold value sw. If this is not achieved, nothing will be done. However, if the signal S exceeds the threshold value sw, a warning signal is issued. Such a signal can be an acoustic signal, an optical signal or a tactile signal, for example the vibration of a handle.
  • the monitoring of at least two threshold values just described applies to all embodiments of the device according to the invention described above.
  • At least one sensor 27 is provided, which detects a motor irritation of the patient, preferably on an extremity of the patient, and that the operation of the generator 20 and thus the voltage on the electrode 18 of the instrument 14 is based on this detected movement being affected.
  • the particular purpose of the influence is to reduce or eliminate the neuromuscular irritation underlying the patient's movement.
  • the surgical device comprises a device 19 with a generator 20 and an instrument 14 which is powered by the generator 20.
  • the device also includes a sensor 27 which, during operation, is attached to the patient, in particular to an extremity, in order to detect a movement of the patient, in particular the extremity.
  • the sensor is connected to a control device 23, which, when the sensor 27 detects a movement of the patient 11 that exceeds a threshold value sa, changes the operation of the generator 20, in particular switches off the generator 20.

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EP19187086.4A 2019-07-18 2019-07-18 Einrichtung zur durchführung eines elektrochirurgischen eingriffs an einem patienten Active EP3766446B1 (de)

Priority Applications (8)

Application Number Priority Date Filing Date Title
EP19187086.4A EP3766446B1 (de) 2019-07-18 2019-07-18 Einrichtung zur durchführung eines elektrochirurgischen eingriffs an einem patienten
PL19187086.4T PL3766446T3 (pl) 2019-07-18 2019-07-18 Urządzenie do wykonywania zabiegu elektrochirurgicznego u pacjenta
RU2020122551A RU2822634C2 (ru) 2019-07-18 2020-07-08 Устройство для осуществления электрохирургического вмешательства на пациенте
US16/923,791 US12042213B2 (en) 2019-07-18 2020-07-08 Device for carrying out an electrosurgical intervention on a patient
JP2020118393A JP7522597B2 (ja) 2019-07-18 2020-07-09 患者に電気外科的処置を実施するための装置
KR1020200086131A KR20210010824A (ko) 2019-07-18 2020-07-13 환자에게 전기수술적 개입을 수행하기 위한 장치
BR102020014310-7A BR102020014310A2 (pt) 2019-07-18 2020-07-14 Dispositivo para realizar uma intervenção eletrocirúrgica em um paciente
CN202010691878.XA CN112315575A (zh) 2019-07-18 2020-07-17 用于在患者上进行电外科手术介入的装置

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EP19187086.4A EP3766446B1 (de) 2019-07-18 2019-07-18 Einrichtung zur durchführung eines elektrochirurgischen eingriffs an einem patienten

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JP (1) JP7522597B2 (pl)
KR (1) KR20210010824A (pl)
CN (1) CN112315575A (pl)
BR (1) BR102020014310A2 (pl)
PL (1) PL3766446T3 (pl)

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RU2204351C2 (ru) 2001-06-25 2003-05-20 Белик Дмитрий Васильевич Импедансный электрохирургический аппарат
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EP2589410B1 (de) * 2011-11-03 2015-02-11 Inomed Medizintechnik GmbH Kontrollanordnung zur intraoperativen Überwachung der Nervenfunktion im Beckenbereich
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CN108882892A (zh) * 2016-03-31 2018-11-23 Zoll医疗公司 跟踪患者运动的系统和方法
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JP7522597B2 (ja) 2024-07-25
EP3766446C0 (de) 2024-02-14
EP3766446A1 (de) 2021-01-20
RU2020122551A (ru) 2022-01-10
CN112315575A (zh) 2021-02-05
KR20210010824A (ko) 2021-01-28
BR102020014310A2 (pt) 2021-04-13
JP2021016784A (ja) 2021-02-15
PL3766446T3 (pl) 2024-05-13
US12042213B2 (en) 2024-07-23
US20210015547A1 (en) 2021-01-21

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